Trials / Recruiting
RecruitingNCT05844982
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Jaeb Center for Health Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.
Detailed description
The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fluorescein angiography and OCTA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faricimab | 6.0 mg intravitreal injection at randomization and every 3 months |
| DRUG | fluocinolone acetonide | 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months |
Timeline
- Start date
- 2023-11-21
- Primary completion
- 2029-12-26
- Completion
- 2029-12-26
- First posted
- 2023-05-06
- Last updated
- 2026-01-29
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05844982. Inclusion in this directory is not an endorsement.